BonE and Joint Infections - Simplifying Treatment in Children Trial
Who is this study for? Patients with Septic Arthritis, Bone and Joint Infection, Osteomyelitis
What treatments are being studied? Cefalexin
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:
• Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.
Locations
Other Locations
Australia
Women's and Children's Hospital
RECRUITING
Adelaide
Queensland Children's Hospital
RECRUITING
Brisbane
Royal Darwin Hospital
RECRUITING
Darwin
Nepean Hospital
NOT_YET_RECRUITING
Kingswood
The Royal Children's Hospital
RECRUITING
Melbourne
John Hunter Children's Hospital
RECRUITING
New Lambton Heights
Perth Children's Hospital
RECRUITING
Perth
Sydney Children's Hospital Network
RECRUITING
Sydney
The Children's Hospital at Westmead
ACTIVE_NOT_RECRUITING
Sydney
New Zealand
Christchurch Hospital
RECRUITING
Christchurch
Contact Information
Primary
Alison Boast, MD
alison.boast@gmail.com
+61393455522
Backup
Amanda Gwee, PhD
amanda.gwee@rch.org.au
+61393455522
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 285
Treatments
Active_comparator: Intervention
Children will receive high-dose oral cefalexin 37.5 mg/kg/dose (max 1.5 g) QID 1 to 7 days followed by oral cefalexin 45 mg/kg/dose (max 1.5 g) TDS for a total course of 3 weeks
Active_comparator: Standard Therapy
Children will receive IV cefazolin 50 mg/kg/dose (max 2 g) three-times daily (TDS) or IV flucloxacillin 50 mg/kg/dise (max 2 g) four-times daily (QID) for 1 to 7 days followed by oral cefalexin 45 mg/kg/dose (max 1.5 g) three-times daily (TDS) for a total course of 3 weeks
Related Therapeutic Areas
Sponsors
Leads: Murdoch Childrens Research Institute